Ranitidine Under Scanner Again: DTAB, CDSCO Recommend New Safety Study, Tighter Monitoring

Following detailed deliberation, the Board recommended the constitution of a larger committee to holistically examine all aspects of the safety profile of ranitidine, particularly the factors contributing to NDMA formation, including storage and stability.

“DTAB further also recommended that ICMR may conduct a study for assessing the safety of ranitidine drug considering the presence of NDMA impurity,” the Board noted in its official minutes.

The Board also emphasized the need for active manufacturer responsibility in monitoring impurity levels. “Manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life,” DTAB advised.

Ranitidine, once widely used to treat heartburn and acid reflux, has faced regulatory scrutiny globally since 2019 after several countries detected NDMA in both over-the-counter and prescription formulations. Many nations, including the U.S. and several in Europe, have since withdrawn or suspended its use.

Also Read: USFDA Requests Removal Of All Ranitidine Products (Zantac) From The Market

Global Timeline of Regulatory Actions on Ranitidine and NDMA:

September 2019: The U.S. FDA issues an alert after detecting NDMA in ranitidine samples.

October 2019: European Medicines Agency (EMA) and Health Canada initiate reviews of ranitidine products.

April 2020: The U.S. FDA requests the withdrawal of all ranitidine products from the American market.

2020–2021: Multiple countries, including Canada, Germany, Switzerland, and France, suspend or withdraw ranitidine due to impurity risks.

India: In 2020, the CDSCO issued alerts to manufacturers and asked them to conduct internal assessments but did not impose a blanket ban.